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- 2026-04-16 04:58:38
- Policy
- Roche approved to release a new drug treating lymphoma
- by Lee, Tak-Sun Oct 30, 2020 05:55am
- A new drug by Roche, Polivy injection (polatuzumab vedotin), is released to the South Korean market to treat patients with lymphoma, a type of blood cancer. The injection, used in combination with bendamustine and rituximab, is expected to be a new option for patients not responsive to the existing treatment. On Oct. 27, the Ministry of Food and Drug Safety (MFDS) green lit Roche Korea’s Polivy injection for the Korean market. The injection, in combination with bendamustine and rituximab, is indicated to treat adult patients, who are not suitable to take a hematopoietic stem cell transplant, but have relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after at least two prior therapies. Eisai’s Symbenda injection is the original bendamustine, and Roche’s Mabthera injection is the original rituximab. Both injections are prevalently used as first-line treatments in patients with DLBCL. Apparently, however, 30 percent of the patients who have used the drugs did not demonstrate satisfying response rate. Polivy injection is an antibody-drug conjugate (ADC) that targets CD79b, a surface immunoglobulin of B lymphocyte antigen receptor. Its clinical studies have confirmed the efficacy in combination with bendamustine and rituximab. The polatuzumab vedotin plus bendamustine plus rituximab combination therapy and bendamustine plus rituximab combination therapy as a reference drug, were administered to 40 patients each to observe their results for 42 months. The Polivy group showed a significantly better complete reaction (CR) of 42.5 percent than the reference drug group reaching 15 percent. The new drug is highly anticipated by a group of patients who could not respond to the existing option of bendamustine plus rituximab combination therapy. Polivy injection has been approved by the U.S. Food and Drug Administration (FDS) in June last year. As the injection was approved as a biological drug that has to submit evidences in-development, MFDS plans to manage the drug with the risk management plan (RMP) even after its market launch.
- Policy
- Can the ICER value increase the range of GDP?
- by Kim, Jung-Ju Oct 30, 2020 05:55am
- The National Assembly is calling for an increase in the incremental cost effectiveness ratio (ICER), which is used as the basis for price determination, for reimbursement of expensive drugs, which is the key to strengthening the coverage of Moon Jae In Care pharmaceutical sector. This is because the price of breakthrough new drugs used for serious diseases is getting higher and higher, and it seems difficult for insurers who manage finances to diagnose as the cause of excessive spending and exceed the current maximum of ICER. The NHIS and The HIRA's recent written responses to the National Assembly's Health and Welfare Committee are summarized, and the position on this is consistent. As of 2018, Korea's health insurance coverage rate was 63.8%, the highest level since 2010. Although it appears to be in the early 60% of the figures, it is interpreted that the driving effect of'Moon Jae-in Care' is significant when considering the rapid change in population diseases, the expansion of expensive drug reimbursement, the increase in natural increase and the balloon effect. The NHIS (left) and The HIRA Severe treatments, anticancer drugs, and drugs for treating rare diseases are the key to strengthening the coverage of the drug sector. As these new drugs become more expensive, the ICER range, which determines the benefit price (insurance ceiling) of these drugs, is also required to be expanded. In fact, on the 22nd, at the general government audit of the Welfare Committee, Minister of Health and Welfare Park Neung-hoo was struggling with a question from Rep. Lee Yong-ho, who raised the need for an upward adjustment of the first-line treatment for the new lung cancer drug Tagriso. At the time, Minister Park explained, "Tagriso's drug price is not a very expensive drug, because new drugs are released every day and there are a lot of very expensive drugs. There are some super expensive drugs that cost 100 million won per administration." Kim Yong-ik, chairman of the NHIS, also said at the NHIS·the HIRA on the 20th, "The listing of new drugs is inevitable. If negotiated, the NHIS or the government, which has to set the drug price, will be in a difficult position." "If this is set up, it can be difficult for patients." Kim Sun-min, Chief of the HIRA was in the same position. He said, "The value of ISR should be effective when you inject additional costs. Recently listed anticancer drugs require as much as 1 billion won or more to extend the average one-year lifespan." also he added, "We need to consider patients with other diseases and discuss with social consensus." Accordingly, Rep. Kang Ki-yoon of the Welfare Committee made a written inquiry to the HIRA, saying that GDP applied to the ICER value should be realized. ICER is a key tool that compares the effects and costs of life extension after one year of taking drugs belonging to the comparative group when evaluating the economics of drugs for which insurance benefits are applied. Korea has dualized drug reimbursement work, and the HIRA is conducting economic evaluation and the NHIS is conducting drug price negotiations. Most of the world's advanced insurance countries that are evaluating the economic feasibility of new drug benefits use the ICER tool to evaluate and deliberate just before drug price negotiations. Usually, the country's GDP level is the reference range. It is threatening the reinforcement of guarantees as there is a growing tendency to derive a price range that is far beyond. Regarding this, the HIRA said, "There is no explicit ICER threshold for determining whether to pay benefits. GDP per capita is based on the 2013 level of 25 million won (1ICER)." We are considering it and evaluating it.” In order to overcome these difficulties and strengthen the security of new drugs, Korea has already established the ICER threshold for new drugs for treatment of severe and rare diseases in the case of new drugs for the treatment of severe and rare diseases, which is 50 million won (2ICER) in GDP. It is applying elasticity to the level. Accordingly, there is a need to further increase the ICER threshold with'Moon Jae-in Care' pursuing a breakthrough strengthening of security. However, it is difficult for the insurer. This is because Moon Jae In Care is being continuously promoted by taking steps as a long-term plan at the government level, so enormous finances are being invested, and in particular, it is self-determining that financial overspending has resulted in increased access to new drugs. The NHIS responded to a written inquiry from Rep. Nam In-soon asking for a reinforcement explanation of Moon Jae-in Care. "The area that needs to be improved" answered. It is said that the ICER threshold expansion is not realistic given the fact that an increase in the ICER threshold will lead to an increase in fiscal expenditure. The HIRA also said, "The ISR threshold adjustment can contribute to strengthening accessibility to new drugs, but it is necessary to collect sufficient social opinions as it is accompanied by additional financial requirements such as an increase in drug prices.
- Company
- Boryung recorded the largest quarterly sales performance
- by An, Kyung-Jin Oct 30, 2020 05:54am
- Boryung Boryung's quarterly performance improved even amid the economic downturn caused by COVID-19. The growth of new drugs introduced by multinational pharmaceutical companies, centering on Kanarb Family developed with their own technology, has contributed to the improvement of the performance of the Prescription drugs division. Boryung announced on the 27th that its operating profit for the third quarter was ₩12.9 billion, an increase of 8.4% year-on-year. During the same period, sales amounted to ₩145.4 billion, a 4.4% increase from the previous year, and net profit fell 2.1% to ₩8.1 billion. The company's third quarter sales are the largest quarterly sales since the company was founded. The new record for the previous quarter was ₩138.9 billion in the fourth quarter of last year. The cumulative operating profit in the third quarter was ₩36 billion, up 10.0% from last year, and sales increased 7.5% to ₩414.1 billion. The reason that Boryung was able to continue its sales increase for three consecutive quarters despite the spread of COVID-19 is due to the sales of Kanarb Family. According to UBIST, a drug market research institute, the outpatient prescription for Kanarb (Fimasartan) in the third quarter was ₩12.6 billion, up 6.2% from ₩11.9 billion a year earlier. The cumulative prescription amount of Kanarb this year was ₩37 billion, up 5.2% from the same period last year. Kanarb is an ARB (Angiotensin II receptor blocker) series hypertension treatment developed by Boryung's own technology. Since its launch in the domestic market in March 2011, it has increased its sales every year, but the rise was even steeper due to Valsartan’s impurity situation two years ago. Boryung steadily launched combination drugs based on Kanarb. The cumulative prescription amount of Dukarb, a combination drug of Kanarb and a calcium channel blocker (CCB) drug Amlodipine, in the third quarter was ₩25.9 billion, up 24.0% from last year. Outpatient prescriptions for Tuvero, which combines Kanarb with Rosuvastatin, a hyperlipidemia drug, and Lacor, which combines Kanarb with a diuretic, cost 3.7 billion won and 5.4 billion won respectively. At the beginning of this year, the prescription of Dukaro, a three-drug drug for hypertension and hyperlipidemia, was worth ₩3.5 billion, and Akarb, a combination drug for hypertension and hyperlipidemia, which was recently released, was prescribed for about ₩100 million. In the third quarter of this year, the cumulative prescription amount of 'Kanarb Family', which includes five types of 'Kanarb' and combined drugs, amounted to ₩75.7 billion. The prescription size increased by 19.0% from last year due to the effect of new product launches. If the current trend continues, the annual prescription amount is expected to exceed ₩100 billion. Prescription drugs, which obtained copyrights from multinational pharmaceutical companies, are also expanding externally. The anti-ulcer drug Stogar has been prescribed for ₩15 billion for 9 months this year, making it a leading prescription item among single H2 receptor antagonists. Stogar is a Rafutidine-based H2 receptor antagonist. At the end of last year, the scale of prescriptions increased by 58.1% in one year due to the suspension of Ranitidine due to the detection of impurities. Trulicity, a GLP-1 analog-based diabetes drug introduced and sold by Eli Lilly, posted a prescription performance of ₩26.1 billion, up 11.8% from the same period last year. Boryung is producing most of the new drugs introduced at its own factory, except for some jointly sold products. This is evaluated as securing higher profitability than other mid-sized pharmaceutical companies in Korea.
- Company
- Novartis "No more order suspension for Myfortic 3rd trial"
- by Kim, Jin-Gu Oct 30, 2020 05:54am
- Although Novatis took an appeal case on the pricing reduction order for Myfortic Enteric Coated Tablet to the Supreme Court, the company has reportedly decided to not request to halt the administration order. Even if the South Korea’s Ministry of Health and Welfare (MOHW) issues an order to bring down the drug pricing according to the second trial, the company means to give up on the request to delay the order execution until the end of the Supreme Court decision. Sources analyze the multinational company has felt the pressure from the National Assembly. According to pharmaceutical industry sources on Oct. 23, Novartis has recently made the decision during an internal meeting. ◆Requested postponement of pricing reduction order criticized as ‘buying time’ Typically, when a pharmaceutical company files litigation against MOHW’s order to reduce the drug pricing, the company simultaneously request the administrative order to be suspended. Basically, the company is asking the court to postpone the pricing reduction until the final decision is made. Most of the court cases accept such request, which is why the public makes reproachful comment about the pricing reduction litigation naming them ‘time-wasting’ or ‘abuse of the judicial system.’ Regardless of the court rules in favor of MOHW’s administrative order, the pharmaceutical company has opportunity to appeal. And for those appeals in the second and third trials, the companies again request the court to suspend the order. Taking the case until the third trial, the company buys time as much as possible before the pricing reduction. As for the company, it is more profitable to file litigation, while maintaining the original pricing and making sales. So far, MOHW won all eight cases of pricing reduction order litigations. Considering the precedents, the public point a figure at companies routinely filing litigation with a hidden agenda to suspend the administrative order. The office of Democratic Party Lawmaker In Jaekeun claimed the NHI financial loss is projected at 150 billion won from 2018 through last July due to repeatedly delayed drug pricing order. ◆The public label litigation ‘time-wasting,’ Novartis says “No more order suspension in third trial” To this date, total 17 cases resembled such case. And Novartis’ Myfortic is a great example. With generics launching in April 2018, MOHW issued a notice stating the pricing of Myfortic would be reduced by 30 percent. The order has been delayed even until now. The tablet is still priced at 1,382 won (180 mg). In last month, the court for the second trial has ruled the same as the first trial and said the order was just. The company relentlessly filed an appeal to the Supreme Court. The pharmaceutical industry suspects Novartis would request for the third suspension on the administrative order when filing the appeal. But the company confirmed the third request would not be made. Novartis official on the phone with Daily Pharm stated, “The company has decided not to seek for administrative order suspension to lessen wasted resources and unnecessary l confusion.” The industry experts analyze the company felt the heavy pressure from the lawmakers at the National Assembly. During the National Assembly annual audit by the Health and Welfare Committee convened on Oct. 13, Lawmaker In Jaekeun criticized “Administrative litigation and request for pricing reduction suspension have ultimately become a formality to solely benefit pharmaceutical companies.” “An indemnity should be demanded or a penalty should be imposed on companies filing money-making litigation that buys time without a clear purpose,” the lawmaker added. ◆Is it fair to order pricing reduction before the final decision on patent litigation is made? Besides the request to halt the administrative order, Novartis has submitted a petition for an appeal and plans to clearly confirm if the pricing reduction order was just. The point of the litigation is to see if it was fair for the government to bring down the original’s pricing, due to a generic launched before the patent litigation was fully concluded. The current regulation allows a generic company to release a follow-on drug, when the company wins during the patent dispute. It does not matter either the Intellectual Property Trial or the Appeal Board (first trial) or the Patent Court (second trial). Once a generic challenges and overcomes the original’s patent, it can be released in the market. And when a generic enters the market, MOHW drops the original’s price. But Novartis claims the pricing reduction before the second or third trial is unfair as sometimes the decision from the first trial could be overturned. The company explains the price reduction during the in between time would make a loss for the company. The Novartis official said, “The company calls for the Supreme Court’s decision to judge if the current government statute regarding the pricing reduction is adequate. During the third trial, the company would assertively appeal the unfairness.”
- Company
- Interview: More options in CDK4/6 inhibitor-Faslodex
- by Eo, Yun-Ho Oct 29, 2020 05:52am
- Professor Kim Ji Yeon The emergence of cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in treatment of patients with human epidermal growth factor receptor 2-negative (HER2-) breast cancer has brought a change in treatment pattern. Technically, chemotherapy was the only option in the hormone receptor-positive (HR+) and HER2- breast cancer. Ibrance (palbociclib), the first CDK4/6 inhibitor to be approved in South Korea in 2016, was already under the limelight from the R&D phase, and it firmly took root in the therapeutic scene as the healthcare reimbursement was granted on the aromatase combination therapy in post-menopausal female patients as the first-line treatment in November 2017. But still, there was an unmet medical needs—the Faslodex (fulvestrant) combination therapy as a second-line therapy. Regardless of relentless attempts to receive the healthcare reimbursement, the indication is yet to be listed for over two years. However, the restraint was lifted in last June. Now, the patients can fully take advantage of the benefits from CDK4/6 inhibitor. And as Verzenio (abemaciclib) and Kisqali (ribociclib) are either listed or to be listed soon, the patients have two more options besides Ibrance. Daily Pharm interviewed Professor Kim Ji Yeon at Samsung Medical Center Hematology-Oncology division and heard her story of the prospects in utilizing CDK4/6 inhibitor. -What is the significance in having the reimbursed option of Faslodex combination therapy? As for a healthcare provider, more than anything, CDK4/6 inhibitor is an option that lessens the concern of ‘relapse.’ Up until recently, the healthcare coverage was limited to the aromatase combination therapy for the first-line treatment. The reimbursement expanding to Faslodex combination therapy is providing benefits to more people, and healthcare providers are now treating the patients in peace. Being able to prescribe a CDK4/6 inhibitor in combination with Faslodex in patients whose cancer advanced after a tamoxifen adjuvant treatment is a blissful option for patients. -With the expanding coverage, follow-on drugs (Verzenio and Kisqali) have also won reimbursements. Especially, soon-to-be-listed Kisqali even covers pre-menopausal female patients. Which factors should patients consider when choosing a CDK4/6 inhibitor? Surely, Kisqali would be prevalently used among pre-menopausal patients. In the past, CDK4/6 inhibitor in combination with an aromatase inhibitor was the only option after prescribing tamoxifen adjuvant hormonal therapy following a bilateral salpingo-oophorectomy (BSO). But now patients skip BSO and simultaneously use Kisqali plus aromatase inhibitor and gonadotropin releasing hormone (GnRH) agonist. The healthcare providers also try to avoid BSO. However, patients using Ibrance or Verzenio after having a BSO do not have to get injected every month. Specifically, Ibrance is prescribed for two to three months’ worth at once as it rarely causes adverse reaction. On the contrary, patients using Kisqali would have to visit hospital to get injected once a month. -You have mentioned Ibrance is advantageous regarding adverse reaction. Does that mean between various CDK4/6 inhibitors, there are differences in adverse reactions? Apparently, the adverse reaction depends on whether the CDK4/6 inhibitor blocks ‘4’ or ‘6’ more, or other types of CDK including CDK2 or hinders cyclin activity. Verzenio and Kisqali tend to frequently cause stomach related adverse reaction. Patients usually complain about having diarrhea with Verzenio and having nausea or indigestion with Kisqali. On the other hand, Ibrance has reported barely any adverse reaction related to stomach. Nevertheless, reduction in neutrocyte and bone density, compared against Verzenio, were more frequently reported from Ibrance. Moreover, Kisqali and Ibrance share similar level of hematological adverse reaction like the reduction in neutrocyte. For instance, most of adverse reaction experienced from using Ibrance is reduction in neutrocyte, whereas Verzenio causes relatively insignificant changes in the neutrocyte level, but more prevalent adverse reactions in stomach are found. But, the patients directly feel the stomach related adverse reactions, when the reduction in neutrocyte level is almost unnoticeable for patients unless they have fever or a drop in immunity level. -It sounds like the preference on Ibrance would be up to patients’ situation It is so. An elderly patient over 70 would highly prefer Ibrance. Even patients in their 60s could prefer Ibrance, if they have underlying diseases like diabetes and hypertension, or not feel the best condition. -But the experts say the downside of Ibrance is no available data on overall survival (OS). Generally, an anticancer treatment clinical trial produces statistics based on a primary endpoint, and prioritizes in improving the Progression Free Survival (PFS) within the smallest group of patients. As a first CDK4/6 inhibitor, Ibrance’ statistics had to focus on PFS than any other endpoint. The first-in-class drugs tend to go through generically conventional design of clinical study. Kisqali’s study was designed to analyze OS and PFS by setting the OS as the key secondary endpoint. A latecomer can learn from the first-in-class drug and take a bolder step in a clinical study. Personally, the most integral factor would be the hazard ratio in PFS. All three of the drugs showed similar level of hazard ratio ranging from 0.5 to 0.6. When CDK4/6 inhibitors’ real world data accumulate in the future, more clear answer would be given. -The recent trend in the indication expansion among anticancer treatments seems to highlight adjuvant therapy after the release to diversify the indication. Do you think the adjuvant therapy is crucial in CDK4/6 inhibitors? To be honest, I am skeptical about the need of patients in stage 2 or earlier taking CDK4/6 inhibitor, while enduring the adverse reaction. As 40 percent to 50 percent of stage 3 patients would relapse, administering CDK4/6 inhibitor for two to three years would make sense when the OS benefit is significant. But, there is also concern about which medication to use when the cancer cells metastasize after using CDK4/6 inhibitor in adjuvant therapy.
- Policy
- Pantoprazole, shouldn’t be exceed 20mg per day
- by Lee, Tak-Sun Oct 29, 2020 05:52am
- Pantoloc, brand for Pantoprazole For Pantoprazole, one of the anti-ulcer PPI, the MFDS is pursuing a change in the approval so that it does not exceed 20 mg per day for patients with severe hepatic impairment. Previously, it was supposed to take 40mg once every other day, but it was not to exceed 20mg per day. The MFDS recently prepared a proposal for amendment of the permission matters and requested related companies to submit their opinions by November 11. The original for Pantoprazole is Takeda's Pantoloc. Pantoloc is a blockbuster drug that recorded ₩14.5 billion in outpatient prescriptions last year. The proposed amendment to this permit applies only to a single drug of Pantoprazole Sodium Hydrate 40mg. A total of 19 pharmaceutical companies and 20 items are licensed. The main changes are the indication and dosage for patients with severe hepatic impairment such as Zollinger–Ellison syndrome and other pathological conditions of gastric acid hypersecretion. It was supposed to take 40mg once every other day, but from now on, it will not exceed 20mg once a day. The MFDS said that, as a result of an additional review on the safety and effectiveness of the update application data, it was determined that changes to the permission matters were necessary, and that a change proposal was prepared. With this change, patients with severe liver impairment cannot take 40 mg tablets at once. Instead, you should take 20mg or 40mg in half. Currently, Pantoprazole’s indication does not exceed 20mg per day for patients with severe hepatic impairment. There was a difference from the 40mg tablet. Accordingly, it is interpreted that the MFDS has devised a plan to change this permission to reduce confusion in taking patients. An official from the MFDS explained that the existing indication doesn’t have safety issues. Pantoprazole 40mg was first approved in 2004.
- Policy
- The MFDS begins preliminary screening for COVID-19 vaccine
- by Lee, Tak-Sun Oct 29, 2020 05:52am
- It was revealed that the domestic health authorities have begun a preliminary review of the COVID-19 vaccine that AstraZeneca is developing. It is explained that applications for domestic approval are expected after three months as soon as possible. Among vaccines currently being developed at home and abroad, it is the fastest for domestic product approval. The MFDS announced on the 27th that AstraZeneca formed a dedicated approval review team for the COVID-19 vaccine being developed and began preliminary review of non-clinical test data. The COVID-19 vaccine being developed by AstraZeneca is a vaccine jointly developed with The Jenner Institute in the UK, and is currently being evaluated for its rapid commercialization. In Korea, SK Bioscience has signed a contract to consign the vaccine. The MFDS is operating one of ‘Go’ Expedited Programs for rapid approval of COVID-19 treatment and vaccine. For products that are expected to apply for permission, 'permission exclusive review team' was formed 90 days before the scheduled application date. And it has a system to proceed with the preliminary examination. Accordingly, the data will be reviewed in advance under the assumption that the AstraZeneca-developed COVID-19 vaccine is applied for approval after 3 months. It plans to review not only non-clinical data but also clinical data in progress overseas. An official from the MFDS said, "AstraZeneca has the only COVID-19 vaccine that is undergoing pre-examination by the approval team." And he added that it plans to review the data before applying for permission. Meanwhile, in Korea, 'INO-4800' of the International Vaccine Institute and 'GX-19' of Genexine are currently in phase I/IIa as a vaccine for COVID-19. The MFDS said that it will continue to monitor development trends, such as clinical trials of COVID-19 treatments and vaccines, and provide support for items such as product approvals, special manufacturing, and imports necessary for domestic introduction. In addition, the MFDS said it will do its best to ensure that the Korean people receive treatment opportunities.
- Company
- MSD has appointed So-eun Kim as the first CEO of Organon
- by Oct 29, 2020 05:51am
- So-eun Kim, the first CEO of Organon & Co. MSD announced on the 27th that it has appointed So-eun Kim (49 years old), currently managing director of MSD Korea, as the new CEO of Organon & Co, which will be newly established through the spin-off in the first half of 2021. Organon & Co's term of office begins on February 1, 2021, when the division of the company in Korea is completed. Since joining MSD Korea in 1998, the new CEO So-eun Kim has played various roles in MSD domestic and overseas for about 23 years. She has served as Head of the External Affairs, Primary Care, and Commercial Operations divisions, and has led Marketing and Sales Excellence (MSE) in Asia Pacific. She has been in charge of the division of the company as a transition lead at MSD Korea since last February. New CEO So-eun Kim said, "Organon & Co. will grow into a global healthcare company that provides specialized solutions for women's health based on the continuous growth of various products such as cardiovascular, respiratory, dermatological, and musculoskeletal systems." She added, "In the case of the Korean branch, we will build a corporate culture so that employees can enjoy various opportunities for growth in a horizontal and flexible environment while pursuing the company's continuous growth and leadership."
- Company
- Evrysdi is expected to enter Korea
- by Eo, Yun-Ho Oct 28, 2020 06:03am
- The third SMA treatment is expected to enter Korea following Biogen's Spinraza approved in 2017 and Novartis' Zolgensma, which is currently undergoing approval review. According to related industries, Roche also submitted an application for Evrysdi (Risdiplam) to the MFDS after approval from the US FDA in August. All of these drugs are treatments for Spinal Muscular Atrophy (SMA), and detailed indications, formulations, dosages, and dosages are different. Zolgensma (Onasemnogene abeparvovec), a gene therapy drug and an expensive drug with a concept of 'one-time treatment', is still under review, and Evrysdi, which is an oral drug and continuously administered, is considered to have relatively shortened the screening period. Evrysdi's indications are for 'adult and infant SMA patients over 2 months'. Evrysdi's FDA approval was based on the results of a FIREFISH study in infants aged 2 to 7 months and SUNFISH in children and adults aged 2 to 25 years. In SUNFISH conducted in 180 SMA type II or III patients, Evrysdi demonstrated motor function improvement at 12 months as measured by MFM-32, a motor function evaluation scale. In addition, in the FIREFISH of infant SMA patients 2-7 months of age after type I, 88% of patients receiving Evrysdi for 2 years continued to survive without a ventilator for 2 years. Over two years, 59% of infants were able to sit without assistance for at least 5 seconds on the basis of the Bailey Infant and Toddler Development Test (BSID-III), which measures total infant and toddler developmental exercise. In addition, 65% of infants were able to hold their neck for 1 year, 29% were able to turn themselves over for 1 year, and 30% were able to stand using supports. Meanwhile, Spinraza (Nusinersen) was listed on the insurance benefit list in April last year, accepting the Refund type and the Expenditure Cap type of the total amount limit of the Risk Sharing Agreement (RSA). At the time, due to the efforts of both the government and pharmaceutical companies, the maximum amount of domestic insurance coverage in Spinraza was set at ₩92,359,131 per bottle. It is unclear how long Zolgensma and Evrysdi will take from domestic approval to reimbursement list.
- Company
- Sanofi launches Dupixent '200mg' in Korea
- by Oct 28, 2020 06:02am
- Sanofi-Aventis Korea (CEO Kyung-eun Bae) announced that it will release Dupixent PFS 200mg (Dupilumab), a biologic drug for atopic dermatitis and asthma on the 26th. Accordingly, Dupixent is available in two doses, 200mg in addition to the 300mg previously released. According to the MFDS, Dupixent 200mg can be used for moderate-severe atopic dermatitis patients aged 12 years or older, weighing less than 60kg. After the initial administration of 400mg, it has been approved as a maintenance dose of 200mg every two weeks. Atopic dermatitis is characterized by the intensity of symptoms such as severe itching, rash, dry skin, cracked skin, crusts, and sores during adolescence. Atopic dermatitis patients with adolescents experience difficulties in school life, such as exclusion and harassment of their peers due to outward symptoms, and negatively affected academic performance. In fact, 46% of adolescent patients answered that symptoms of atopic dermatitis affect their school life, and about 26% of patients said they felt a high level of anxiety disorder. Dupixent 200mg has been tested for efficacy and safety profile in LIBERTY AD ADOL clinical trials. In this study involving 251 patients with moderate-severe atopic dermatitis, the Dupixent 200mg and 300mg groups showed a 66% improvement in lesion size and severity at 16 weeks. There was a clinically significant improvement in the quality of life index. Hee-kyung Park, president of Sanofi Genzyme, a specialty care division of Sanofi-Aventis Korea, said, "We are pleased to be able to introduce all of the new doses of Dupixent in Korea." "We look forward to improving their accessibility, and we will do our best to make Dupixent an innovative treatment option for suffering patients in the future."
